Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis - Tabular View

Tracking Information
First Received Date ^ICMJE	May 20, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	April 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00037687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis
Official Title ^ICMJE	A Phase 3 Study to Demonstrate the Safety and Efficacy of Recombinant Platelet-Activating Factor Acetylhydrolase (rPAF-AH, Pafase®) for Reducing 28 Day All Cause Mortality in Patients With Severe Sepsis
Brief Summary	The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.
Detailed Description	This study is a randomized, double-blind, placebo-controlled, multicenter study of rPAF-AH compared to placebo in patients with severe sepsis. Eligible patients from investigative sites located throughout the United States and other countries will be randomized to receive either rPAF-AH or placebo administered daily for five consecutive days by intravenous (IV) infusion. All patients will be evaluated for safety and efficacy endpoints over 28 days. A follow-up evaluation will occur approximately 6 months after Day 28 to assess functional status and quality of life.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Sepsis
Intervention ^ICMJE	Drug: rPAF-AH
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	2500
Completion Date	December 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion criteria Clinical diagnosis of severe sepsis At least 18 years old Patient or legally authorized representative able to provide informed consent Exclusion criteria Severe lung injury (acute respiratory distress syndrome) Immunocompromised Severe liver disease Inflammation of the pancreas, organ rejection, or burns to more than 30% of body Enrolled in another clinical trial Already participated in this or other rPAF-AH study There is not a commitment to aggressive treatment Has a disease with life expectancy less than 6 months
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00037687
Responsible Party
Study ID Numbers ^ICMJE	BAR03, BB-IND 9538
Study Sponsor ^ICMJE	ICOS Corporation
Collaborators ^ICMJE	Suntory Pharmaceutical
Investigators ^ICMJE
Information Provided By	ICOS Corporation
Verification Date	January 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP